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Medtronic Heart Lead Recall | Medtronic Recall FAQ
Quick Facts on the Recall | Know Your Legal Rights
Resources and Documents | Recall Attorney Contact
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Image: Gavel  Our Promise to You

Clients represented by our firm filed the first personal injury lawsuits in the nation against Medtronic.

We have been appointed to a leadership role among plaintiffs' counsel in the litigation against Medtronic in federal court.

Our injury lawyers have years of experience successfully representing clients in personal injury cases. We provide each client with high-level individualized representation.

There is no charge or obligation for our review of your injury lawsuit.

We have retained product safety and medical experts nationwide to assist our clients with their claims.

In addition to a team of experienced lawyers, we have dedicated nurses, legal assistants and case clerks to assist our attorneys in the Medtronic recall litigation. Our firm has six full-time nurses, including ones with decades of experience working with heart patients.

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Image: Computer Mouse  Free Case Evaluation

Lieff Cabraser represents persons across America injured by the Medtronic Sprint Fidelis heart lead. Click here to contact an experienced injury attorney at Lieff Cabraser for a free case evaluation. Or call us toll-free at 1-800-948-2181.

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Image: Newspaper  Medtronic News

Read excerpts from the latest news covering the Medtronic recall and lawsuits:

Read excerpts from the latest news covering the Medtronic recall and lawsuits

Lieff Cabraser had been investigating patient complaints concerning the Medtronic heart lead prior to the recall announced by Medtronic. On the same day as the recall, heart patients nationwide represented by Lieff Cabraser and co-counsel filed separate personal injury and class action lawsuits against Medtronic.

May 16, 2008
"Heart Device Patients Often Unaware of Recalls"

May 7, 2008
"Medtronic to Cut About 1,100 Jobs"

all news >>>    

 
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Public Citizen Medtronic
Letter - Oct. 16, 2007

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Letter to the FDA urging an investigation of Medtronic defibrillator recall (HRG Publication #1826)
 
October 16, 2007
 
Andrew von Eschenbach, MD, Commissioner
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
 
Dear Dr. von Eschenbach:
 
Important live-saving facts seem to have been overlooked intentionally by both the FDA and Medtronic while the two were busy congratulating one another for doing a better job detecting and recalling the Medtronic Sprint Fidelis defibrillator lead than Guidant did in its product recall several years ago.
 
I urge you to conduct an immediate investigation concerning the following:
 
1. The total number of reports of injury associated with the Fidelis lead had climbed to 599 by Jan. 10 2007, including 204 cases in which patients received “inappropriate shocks.” (See Table and Figures 1 and 2 below.) The number of injury reports for the first two months of 2007 was 152, compared with 27 reports for the first two months of 2006. Some of this reflects the fact that the longer the defibrillator is implanted, the greater likelihood there is of a fracture, inappropriate shock or other medical problem with the lead.
 
Why did the FDA, aware of the rapidly mounting number of injury reports, not force the company to recall defibrillators not yet implanted in the early part of this year? It is likely that the 1,030 injuries reported to the FDA after Jan. 10 included many patients with defibrillators implanted after this date. Had the recall and further implantations stopped then – instead of nine months later (this week) – many patients would have been spared the injuries and anxiety that occurred with these recent implantations.
 
Medtronic had been warned about the injuries. Dr. Robert Hauser of the Minneapolis Heart Institute says he contacted Medtronic in early February about the problem and published a review of the injury cases in late March. Indeed, The Heart Institute was so concerned about the risk that it ceased implantation of these defibrillators in January. (Conversation with Dr. Robert Hauser, October 16, 2007.)
 
2. As of January, Medtronic and the FDA already were aware of an escalating number of reports of injury in patients with this Fidelis lead. By Jan. 10, the cumulative number of injury reports associated with this lead reported to the FDA database was 599, including 204 cases in which patients got inappropriate electric shocks from their defective defibrillators. (See table below.) Despite this strong warning signal about these defective components, in the same month, January, Medtronic launched a massive direct-to-consumer advertising campaign to lure patients to seek advice from their doctors as to whether they could benefit from having a defibrillator implanted.
 
 
All Injuries
Inappropriate Shock
Jan 10, 2007 and before
599
204
After Jan 10, 2007
1030
563
TOTAL
1629
767
 
The $100 million Medtronic ad campaign, dubbed “What’s Inside,” including a commercial in which a soft voice promises viewers that inside the device, they’ll find "10,000 more kisses ... 200 more football wins," saying it will "always be there for you – close to your heart with the power to restart it in case of sudden cardiac arrest." The ad was clearly trying to frighten people, including many who would not be candidates for such devices. The goal? Turn that fear into a “let’s not take a chance” mentality that results in more consumers, inadequately informed by the ad, asking their doctors for the devices. Why did the FDA, aware of the rising toll of injuries from Medtronic defibrillators, not stop this advertising campaign?
 
Chart
 
chart
 
In summary, the congratulatory comments by both the FDA and Medtronic have covered up the serious problems of the failure of an earlier recall and the FDA’s failure to stop Medtronic’s outrageous and irresponsible Medtronic direct-to-consumer ad campaign.
 
We look forward to a prompt response to these serious problems.
 
Sincerely,

Sidney M. Wolfe, MD
Director

Eunice Yu, Staff Researcher
Health Research Group of Public Citizen


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About Lieff Cabraser

Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is an over fifty attorney law firm with offices in San Francisco, New York and Nashville. For the last five years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiff law firms in America.

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TRADEMARK NOTICE: "Medtronic" is a trademark of Medtronic, Inc. Lieff Cabraser is in no way affiliated with Medtronic, Inc. The use of this mark is solely for informational and product identification purposes.